Antigen of a human retrovirus, namely p18 protein of human immunodeficiency virus (HIV), compositions containing the antigen, a diagnostic method for detecting acquired immune deficiency syndrome (AIDS) and pre-AIDS and a kit therefor

Abstract

Protein compositions containing proteins of the lymphadenopathy virus, which compositions are used for diagnosis of antibodies of such protein in biological fluids, especially blood serum, for the detection or absence of infection. Such compositions contain typically the p18, p13 and/or p25 proteins.

We claim: 
     
       1. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises contacting isolated p18 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and   detecting the formation of the complex.   
     
     
       2. The method as claimed in claim 1, wherein the detecting step further comprises measuring the formation of said complex. 
     
     
       3. The method as claimed in claim 1, wherein the biological fluid is human serum. 
     
     
       4. Structural protein of Human Immunodeficiency Virus (HIV), which is p18 protein of said virus, and said protein is in isolated form. 
     
     
       5. A labeled polypeptide, wherein the polypeptide is capable of being immunologically recognized by serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS);   the polypeptide is p18 protein of Human Immunodeficiency Virus (HIV) in isolated form; and   said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label.   
     
     
       6. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (pre-AIDS), which method comprises contacting an isolated antigen mixture comprising   (A) p18 protein of said retrovirus, and   (B) p25 protein of said retrovirus, with a biological fluid, for a time and under conditions sufficient for the antigen and antibody in the biological fluid to form an antigen-antibody complex; and   detecting the formation of the complex.   
     
     
       7. An isolated mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are p18 and p25 proteins. 
     
     
       8. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises contacting p12 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and   detecting the formation of the complex.   
     
     
       9. Structural protein of Human Immunodeficiency Virus (HIV), which is p12 protein of said virus, and said protein is in isolated form. 
     
     
       10. A labeled polypeptide, wherein the polypeptide is capable of being immunologically recognized by antibodies in the serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS);   the polypeptide is p12 protein of Human Immunodeficiency Virus (HIV) in isolated form; and   said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label.   
     
     
       11. A mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are selected from the group consisting of p12, p18, and p25 proteins, and the mixture is in isolated form.